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510(k) K915650

HUMAN IGG SUBCLASS RID KIT by Janssen Biochimica — Product Code CGM

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 26, 1992
Date Received
December 18, 1991
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Method, Immunodiffusion, Immunoglobulins (G, A, M)
Device Class
Class II
Regulation Number
866.5510
Review Panel
IM
Submission Type

Other clearances for product code CGM

  • K920006 — IL TEST IMMUNOGLOBULIN G (IGG) (March 13, 1992)
  • K920370 — ISOTYPES HUMAN IGG SUBCLASS EIA KIT (March 11, 1992)
  • K920008 — IL TEST IMMUNOGLOBULIN M (IGM) (March 11, 1992)